Psoriasis、Indigo Naturalis、Chinese Medicine Medicated Bath

Pilot Study of Chinese Medicine Medicated Bath as Complementary Medicine for Mild to Moderate Plaque -Type Psoriasis Patient.

Psoriasis is a chronic inflammatory skin disease. Plague-type psoriasis is the most common form of the disease, occurring in more than 80% of the cases. This type of psoriasis is characterized by sharply dermatcated, erythematous, scaling plagues that typically affect the elbows, knees, scalp, and trunk. Estimates of the prevalence of psoriasis was vary from 0.5% to 4.6%, with rate varying between countries and races. The prevalence of psoriasis was about 2% in Taiwan. The etiology of psoriasis remains unknown; however, current research mostly indicated that psoriasis was caused by multiple factors, and it was highly related to Th-17 immunal pathway.Treatment of psoriasis included topical therapy, phototherapy and systemic therapy. Although beneficial, those therapies often caused undesirable adverse effects. Traditional Chinese medicine is one of the most fuguently chosen alternative therapies in China and Taiwan, and psoriasis has been treated for centuries with topical and oral herbal prepations. Chinese medicine medicated bath is a characteristic therapy of Traditional Chinese medicine. It combines both hot bath and herbs to enhance absorption of the effective ingredients of herb. There were reports about the application of Chinese medicine medicated bath to treat psoriasis patients in China. We also used Chinese medicine medicated bath (Jing-Fu-Yau-Yu-Bau) as a complementary therapy of psoriasis patients for a long time in China Medical University Hospital. The patient felt well after using Jing-Fu-Yau-Yu-Bau. The component of Jing-Fu-Yau-Yu-Bau is paper mulberry leaf. The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent. It can clear heat, cool blood and relieve itching. Based on the 83 journal paper we searched on PubMed, there had been extracted a great deal of phenolics, terpenes and flavonoids from paper mulberry leaf that had antibacterial, antifungal, antioxidant and antineoplastic effects.

This is a single site, randomized, single-blind, controlled pilot study of Jing- Fu-Yau-Yu-Bau as a complementary therapy to treat mild to moderate plaque- type psoriasis during an 8-week period. We estimate to enroll 30 subjects (treatment group(N=15); controlled group(N=15)). We plan to investigate the efficacy and safety of Jing-Fu-Yau-Yu-Bau in Chinese subjects with mild to moderate plaque-type psoriasis.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Drug: paper mulberry leaf; Drug: Triamcinolone (Encort-A) 0.1%15g/Tube

Detailed Description

This is a single site, randomized, single-blind, controlled pilot study of Jing- Fu-Yau-Yu-Bau as a complementary therapy to treat mild to moderate plaque- type psoriasis during an 8-week period. We estimate to enroll 30 subjects (treatment group(N=15); controlled group(N=15)).

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • No. 91, Xueshi Rd., North Dist., Taichung City 404, Taiwan (R.O.C.)
    • Contact: Hui-Man Cheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 20-65 years,
• had a diagnosis of plaque-type psoriasis for ≥6 months,
• a Physician's Global Assessment (PGA) score of 2-3, <20% total body surface area (BSA) involvement, and a target plaque of ≥4 cm2.

Exclusion Criteria:

• non-plaque psoriasis,
• rebound/flare of chronic psoriasis,
• history of psoriatic arthritis,
• current drug-induced psoriasis,
• pregnant/nursing/planning pregnancy (men and women),
• used biologics within 3 months or 5 times the half-life,
• received phototherapy/systemic treatment within 4 weeks,
• topicals within 2 weeks,
• any systemic immunosuppressants within 4 weeks, -lithium/antimalarial/intramuscular gold within 4 weeks,
• tested positive for HIV/hepatitis B/C,
• had a history of alcohol/drug abuse,
• clinically-significant laboratory abnormality,
• sensitivity to Chinese herbs ,or allergy to leaf of paper mulberry.
• had skin wound or skin infection
• had current signs/symptoms of severe, progressive, or uncontrolled medical conditions, or were participating concurrently in an investigational study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: chinese medicine medicated bath; we used the leaf of paper mulberry as chinese medicine medicated bath. Two packs per day ,and the period of treatment will be two month.	Drug: paper mulberry leaf; Topical steroids+paper mulberry leaf The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent.; Other Names: Triamcinolone (Encort-A) 0.1%15g/Tube; Encort-A; Drug: Triamcinolone (Encort-A) 0.1%15g/Tube; only Topical steroids; Other Names: Encort-A
Active Comparator: control group; Topical steroids	Drug: Triamcinolone (Encort-A) 0.1%15g/Tube; only Topical steroids; Other Names: Encort-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
participants achieving either a major clinical response or partial clinical response defind by Psoriasis Area Severity Index(PASI) over the 8 weeks treatment period.	Psoriasis Area Severity Index(PASI) is usually measure the clinical activity diseases of psoriasis.	baseline to 8 weeks

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Study Chair: Hui-Man Cheng, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): March 3, 2020

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 13, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
• Other Study ID Numbers: CMUH107-REC2-182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No